|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsored by: |
Federal University of Rio Grande do Sul |
|---|---|
| Information provided by: | Federal University of Rio Grande do Sul |
| ClinicalTrials.gov Identifier: | NCT00305370 |
Purpose
There is a scarcity of clinical trials assessing the effects of medications in children with bipolar disorder.
This study aims to assess the efficacy of Aripiprazole associated with Methylphenidate (MPH)for the treatment of children and adolescents with bipolar disorder comorbid with ADHD who improve in maniac symptoms while receiving aripiprazole but did not have an adequate response in ADHD symptoms. The study design is a 4-week randomized, double blind, cross-over group trial. Patients were randomized to aripiprazole + MPH or aripiprazole + placebo.
The main hypothesis is: Aripiprazole + MPH will significantly reduce ADHD scores compared to aripiprazole + placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
Bipolar Disorder Attention Deficit Hyperactivity Disorder |
Drug: Aripiprazole |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
| Official Title: | Aripiprazole Associated With Methylphenidate in Children and Adolescents With Bipolar Disorder and ADHD: A Randomized Cross-Over Placebo Controlled Trial |
| Estimated Enrollment: | 20 |
| Study Start Date: | August 2005 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Bipolar disorder (BD) is a chronic disorder that severely affects the normal development of children and adolescents. The disorder is associated with high rates of suicide and high-risk behaviors like sexual promiscuity and drug abuse. Bipolar disorder in children is also associated with high rates of comorbidity, especially with Attention-Deficit Hyperactivity Disorder (ADHD). There is a scarcity of clinical trials assessing the effects of medications in children with BD. Moreover, the frequent presence of comorbid ADHD might determine lower response to treatment. Aripiprazole is a novel anti-psychotic drug. Its mechanism of action seems to be related to a stabilization of dopaminergic transmission, acting as a partial agonist especially in dopaminergic D2 receptors. It also has effects in 5-HT1a serotonergic receptors. Thus, it might have a promising effect in children and adolescents with comorbid BD and ADHD. A retrospective chart review, recently published, suggests the efficacy of this drug in children with BD. This study aims to assess the efficacy of Aripiprazole associated with Methylphenidate (MPH) for the treatment of 20 children and adolescents (age range: 8 to 17 years-old) with Bipolar Disorder comorbid with ADHD who improve in maniac symptoms while receiving aripiprazole but did not have an adequate response in ADHD symptoms. The study design is a 4-week randomized, double blind, cross-over group trial. Patients were randomized to aripiprazole + MPH or aripiprazole + placebo. The hypotheses are: 1) Aripiprazole + MPH will significantly reduce ADHD scores compared to aripiprazole + placebo. 2) Patients receiving aripiprazole + MPH will not deteriorate in maniac symptoms.
Eligibility| Ages Eligible for Study: | 8 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Brazil, RS | |
| ADHD Outpatient Program | |
| Porto Alegre, RS, Brazil, 90035-003 | |
| Principal Investigator: | Luis A Rohde, MD | Federal University of Rio Grande do Sul |
More Information
| Study ID Numbers: | GPPG03-325b |
| Study First Received: | March 19, 2006 |
| Last Updated: | August 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00305370 History of Changes |
| Health Authority: | Brazil: National Committee of Ethics in Research |
|
clinical trial aripiprazole methylphenidate |
Bipolar Disorder Attention-Deficit Hyperactivity Disorder ADHD |
|
Dopamine Uptake Inhibitors Neurotransmitter Agents Tranquilizing Agents Bipolar Disorder Psychotropic Drugs Central Nervous System Depressants Methylphenidate Attention Deficit and Disruptive Behavior Disorders Central Nervous System Stimulants Antipsychotic Agents Dyskinesias Signs and Symptoms |
Affective Disorders, Psychotic Dopamine Attention Deficit Disorder with Hyperactivity Mental Disorders Mental Disorders Diagnosed in Childhood Mood Disorders Hyperkinesis Neurologic Manifestations Dopamine Agents Psychotic Disorders Aripiprazole |
|
Dopamine Uptake Inhibitors Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Methylphenidate Signs and Symptoms Affective Disorders, Psychotic Pathologic Processes Attention Deficit Disorder with Hyperactivity Mental Disorders Therapeutic Uses Mental Disorders Diagnosed in Childhood Hyperkinesis |
Aripiprazole Tranquilizing Agents Disease Bipolar Disorder Nervous System Diseases Central Nervous System Depressants Attention Deficit and Disruptive Behavior Disorders Central Nervous System Stimulants Antipsychotic Agents Dyskinesias Pharmacologic Actions Mood Disorders Neurologic Manifestations Dopamine Agents Central Nervous System Agents |
